The Auditing Group, Inc. (TAG) - Provides extensive Auditing, Training and Remediation services supporting regulated industries working under various standards (cGMP, cGCP, cGLP, Systems) with one goal, to provide reliable Auditing, Remediation, Validation, Consulting, Training, and Quality Assurance services that efficiently provide the assistance needed to help our clients succeed.
- GMP Audits - Bio-pharmaceuticals - Excipients and APIs
- GMP Audits - Medical Device - ISO 13485 - EU 745 & 746/2017
- GLP Audits - 21 CFR Parts 58, 210/211 and Pre-Clinical
- 21 CFR Part 11 Electronic Systems & Software
- Food & Dietary Supplements
- Company Acquisitions & Risk Assessments
- Mock FDA, PAI, EU, MNPA and WHO Audits
- Remediation and Validation Services
- Quality Management System (QMS) Audits (GMP)
||Conduct a 'Due-Diligence cGMP Quality System Audit and Gap Analysis Today!
All of our Subject Matter Experts (SMEs) have the Experience, Training, Education and Background to support your compliance audit and remediation requirements backed by the TAG, ASQ and Global Accepted Certifications!
CAPA Manager and CAPA Management Services
Practical CAPA Solution.
We are here, Always Managing, so you do not have to!
CAPA Managers specializes in helping corporations and small businesses with all their CAPA Compliance needs. Because we are well versed in law pertaining to the Code of Federal Regulations (CFRs) pertaining to the Food and Drug Industry, we know exactly what it takes to help you in all your Compliance endeavors.
You purchased the handbooks from GMP Publications and now what?
1. Do you have the resources to conduct proper training against the Regulations based upon applicability?
2. Have you conducted a formal Gap Analysis against the Regulations?
If not, consider TurnKey QMS and The Auditing Group, together assisting firms to meeting and exceed GMP requirements.
Do you need to?
First, Understand the FDA Thinking;
If products, or services, or any action, in whole or in part, which may impact either directly or indirectly, is distributed, adhered, affixed, consumed, or used by a Consumer or Patient, either by Use, Ingestion, Injection, Inhalation, and/or Permeation, they must follow GMPs, or…
If a product is manufactured, or services rendered which greatly benefits the safety, health or welfare of a consumer or patient, directly, and/or indirectly, or…
If a Product or Data which may influence, form a decision for, or create an adverse reactionary event to the health, safety, welfare of a Consumer or Patient, directly or indirectly;
You must comply to the GMPs!
So, what is a Product? What are Services? What are Data? What is direct and/or Indirect impact?
Your applicability to the Federal Regulations is based upon the Product, Service or Data that you provide. And the question is, what is your applicability, directly and/or indirectly?
And this is the hardest concept to understand.